Biotech Archives - Page 59 of 795

2 minute read

Treatment Patch For Schizophrenia: Newly Listed Alto Neuroscience Is Uniquely Positioned In Neuropsychiatry Landscape

April 23, 2:55 PM

Alto Neuroscience reported positive results for its novel PDE4 inhibitor in a Phase 1 study for cognitive impairment associated with schizophrenia.

ANRO

1 minute read

Novartis Radioligand Therapy Lutathera FDA Approved First Medicine Specifically For Pediatric Patients With Gastroenteropancreatic Neuroendocrine Tumors

By Benzinga Newsdesk

April 23, 2:15 PM

https://www.novartis.com/news/media-releases/novartis-radioligand-therapy-lutathera-fda-approved-first-medicine-specifically-pediatric-patients-gastroenteropancreatic-neuroendocrine-tumorsApproval based on NETTER-P trial

NVS

2 minute read

Neurocrine Biosciences Says Treatment Can Alleviate Several Symptoms Associated With Depressive Disorder

By Vandana Singh

April 23, 1:28 PM

Neurocrine Biosciences reports Phase 2 data for NBI-1065845 in major depressive disorder. Results show significant improvement in MADRS scores. William Blair sees the potential for $1 billion+ in sales.

NBIX

2 minute read

This Pharma Co. Kicks Off FDA Approval Process For CBD-Based Treatment Of Chronic Pain

By Jelena Martinovic

April 23, 10:24 AM

Innocan Pharma Corporation (CSE: INNO) (FSE: IP4) (OTCQB: INNPF) announced on Monday that it has submitted its letter of application for a Pre-IND meeting with the U.S. Food and Drug Administration (FDA, for its Liposome-Cannabidiol (LPT-CBD) injectable treatment of chronic pain. With the move, the company initiated the regulatory process with the FDA for the approval of its prolonged CBD release technology for human use.

CSE:INNO

2 minute read

FDA Approves ImmunityBio’s Bladder Cancer Drug, Stock Rallies

By Vandana Singh

April 23, 9:54 AM

FDA approves ImmunityBio's Anktiva plus Bacillus Calmette-Guérin for BCG-unresponsive non-muscle invasive bladder cancer. Anktiva shows promising complete response rates and duration exceeding 24 months.

IBRX

1 minute read

FDA Rejects Approval Of Abeona Therapeutics’ Skin Disorder Treatment, Shares Sink

By Vandana Singh

April 23, 9:43 AM

Abeona Therapeutics' pz-cel gets the FDA's Complete Response Letter and Abeona's plans for fulfilling Chemistry Manufacturing and Controls requirements.

ABEO

2 minute read

Novartis Stock Gains On European Drugmaker’s Q1 Earnings Surprise, Lifts Annual Outlook

By Vandana Singh

April 23, 8:25 AM

Discover Novartis' Q1 EPS soars 17% to $1.80, surpassing estimates. Sales hit $11.83B, up 10%. Entresto sales surge 36%, Cosentyx up 25%. CEO Vas Narasimhan bullish on mid & long-term growth.

BMY

2 minute read

Azitra, Inc. Announces Preclinical Data From The Co’s Platform And Pipeline On Friday, May 10, 2024, In Two Oral Sessions Entitled “Engineered Staphylococcus Epidermidis As A Protein Delivery System For Treating Skin Diseases” And “Staphylococcus Epide…

By Benzinga Newsdesk

April 22, 4:40 PM

Azitra will present two oral presentations at ASGCT (American Society of Gene and Cell Therapy) Baltimore, MD, May 7-11, 2024 related to ATR-12, Azitra's candidate for Netherton syndromeTopical application of ATR-12 to

AZTR

2 minute read

Abeona Therapeutics Provides Regulatory Update On Pz-cel; CRL Did Not Identify Deficiencies Related To Clinical Efficacy Or Clinical Safety Data In BLA, And No New Clinical Studies Requested By FDA To Support Approval

By Benzinga Newsdesk

April 22, 4:06 PM

Receives FDA Complete Response Letter (CRL) based on need for additional CMC information CRL did not identify deficiencies related to clinical efficacy or clinical safety data in BLA, and no new clinical studies

ABEO

2 minute read

US Supreme Court Declines To Hear Vanda Pharmaceuticals’ Case Regarding Invalidation Of Patents For Its Sleep Disorder Drug, Hetlioz

By Vandana Singh

April 22, 2:37 PM

"Supreme Court denies review of Vanda Pharmaceuticals' patent revival attempt for Hetlioz sleep-disorder medication. Legal battle details, implications, and market impact."

TEVA